Cleared Traditional

K063239 - LIFESHIELD LATEX-FREE GRAVITECH FLOW CO...

K063239 is the FDA 510(k) clearance for LIFESHIELD LATEX-FREE GRAVITECH FLOW CO... by Hospira, Inc.. It is a Class 2 General Hospital device (product code FPK) cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K063239 · Hospira, Inc. · General Hospital
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Optimized for regulatory review, auditing and printing
Dec 2006
Decision
46d
Days
Class 2
Risk

K063239 is an FDA 510(k) clearance for the LIFESHIELD LATEX-FREE GRAVITECH FLOW CONTROLLER I.V. SETS, MODELS 17528, 1752.... Classified as Tubing, Fluid Delivery (product code FPK), Class II - Special Controls.

Submitted by Hospira, Inc. (Lake Forest, US). The FDA issued a Cleared decision on December 11, 2006 after a review of 46 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Hospira, Inc. devices

Submission Details

510(k) Number K063239 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 2006
Decision Date December 11, 2006
Days to Decision 46 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 129d · This submission: 46d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FPK Tubing, Fluid Delivery
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FPK Tubing, Fluid Delivery

All 14
Devices cleared under the same product code (FPK) and FDA review panel - the closest regulatory comparables to K063239.
MEDTRONIC MINIMED LEAPFROG II INFUSION SET, MODELS MMT-801S1, MMT-801L1, MMT-801S2, MMT-801L2, MMT-803S1
K052431 · Medtronic Minimed · Nov 2005
EMPOWER TRANSFER SET, (CAT. NO. 7725)
K041178 · E-Z-Em, Inc. · Jul 2004
MEDRAD SWABBABLE VALVE TRANSFER SET
K031808 · Medrad, Inc. · Jul 2003
MEDRAD TRANSFER SET
K022431 · Medrad, Inc. · Sep 2002
POLYFIN EXTENSION SET, MODELS 126 AND 128
K965208 · Medtronic Minimed · Feb 1997
OPHTHALMIC FLUID DISTRIBUTION SETS
K923972 · Visitec Co. · Nov 1992